WO2024079648A1 - Système d'administration pour la libération contrôlée d'un composé psychédélique, composition pharmaceutique et utilisations associées - Google Patents

Système d'administration pour la libération contrôlée d'un composé psychédélique, composition pharmaceutique et utilisations associées Download PDF

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Publication number
WO2024079648A1
WO2024079648A1 PCT/IB2023/060211 IB2023060211W WO2024079648A1 WO 2024079648 A1 WO2024079648 A1 WO 2024079648A1 IB 2023060211 W IB2023060211 W IB 2023060211W WO 2024079648 A1 WO2024079648 A1 WO 2024079648A1
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WO
WIPO (PCT)
Prior art keywords
delivery system
controlled release
psychedelic
release delivery
psilocybe
Prior art date
Application number
PCT/IB2023/060211
Other languages
English (en)
Inventor
Luca Santi
Luigi Mondello
Anna NOTTI
Ilaria CACCIOTTI
Salvatore Cuzzocrea
Original Assignee
Sintalica S.R.L.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sintalica S.R.L. filed Critical Sintalica S.R.L.
Publication of WO2024079648A1 publication Critical patent/WO2024079648A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/357—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having two or more oxygen atoms in the same ring, e.g. crown ethers, guanadrel
    • A61K31/36—Compounds containing methylenedioxyphenyl groups, e.g. sesamin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/48—Ergoline derivatives, e.g. lysergic acid, ergotamine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/66—Phosphorus compounds
    • A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin

Abstract

Un système d'administration à libération contrôlée comprenant : a) des sphères polymères comprenant au moins un composé psychédélique de la classe des tryptamines, des phénéthylamines et/ou des lysergamides, de préférence de la psilocybine, de la psilocine, du LSD, du DMT, de l'ibogaïne, de la mescaline, de la MDMA et/ou des sels, des dérivés, un hydrate ou un solvate de ceux-ci et/ou une combinaison de ceux-ci, et b) une membrane fibreuse polymère. Ledit système d'administration à libération contrôlée est destiné à être utilisé dans le traitement de la fibromyalgie, de la douleur neuropathique chronique induite par une lésion de la moelle épinière, de la douleur neuropathique associée à la neuropathie périphérique diabétique, de la névralgie post-herpétique, de la douleur musculo-squelettique chronique et/ou d'une maladie inflammatoire induite par TNF-α.
PCT/IB2023/060211 2022-10-11 2023-10-11 Système d'administration pour la libération contrôlée d'un composé psychédélique, composition pharmaceutique et utilisations associées WO2024079648A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT202200020898 2022-10-11
IT102022000020898 2022-10-11

Publications (1)

Publication Number Publication Date
WO2024079648A1 true WO2024079648A1 (fr) 2024-04-18

Family

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PCT/IB2023/060211 WO2024079648A1 (fr) 2022-10-11 2023-10-11 Système d'administration pour la libération contrôlée d'un composé psychédélique, composition pharmaceutique et utilisations associées

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WO (1) WO2024079648A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021255252A1 (fr) * 2020-06-19 2021-12-23 Cannovex Bv Formulation comprenant des cannabinoïdes
US20220054402A1 (en) 2020-11-05 2022-02-24 Richard C Kaufman Compositions and methods for extracting, stabilizing, and manufacturing stable dosage forms of psilocin, psychedelic drugs, entheogens, and medicinal mushrooms as nano-dimensional drug delivery structures
US20220088041A1 (en) * 2019-04-17 2022-03-24 Compass Pathfinder Limited Method for treating anxiety disorders, headache disorders, and eating disorders with psilocybin
US20220096504A1 (en) * 2019-01-30 2022-03-31 Diamond Therapeutics Inc. Methods and compositions comprising a 5ht receptor agonist for the treatment of psychological, cognitive, behavorial, and/or mood disorders
US20220304980A1 (en) * 2019-07-04 2022-09-29 SW Holdings, Inc Metered dosing compositions and methods of use of psychedelic compounds

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20220096504A1 (en) * 2019-01-30 2022-03-31 Diamond Therapeutics Inc. Methods and compositions comprising a 5ht receptor agonist for the treatment of psychological, cognitive, behavorial, and/or mood disorders
US20220088041A1 (en) * 2019-04-17 2022-03-24 Compass Pathfinder Limited Method for treating anxiety disorders, headache disorders, and eating disorders with psilocybin
US20220304980A1 (en) * 2019-07-04 2022-09-29 SW Holdings, Inc Metered dosing compositions and methods of use of psychedelic compounds
WO2021255252A1 (fr) * 2020-06-19 2021-12-23 Cannovex Bv Formulation comprenant des cannabinoïdes
US20220054402A1 (en) 2020-11-05 2022-02-24 Richard C Kaufman Compositions and methods for extracting, stabilizing, and manufacturing stable dosage forms of psilocin, psychedelic drugs, entheogens, and medicinal mushrooms as nano-dimensional drug delivery structures

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
OSTADKARAMPOUR, M. ET AL.: "Monoamine oxidase inhibitors: a review of their anti-inflammatory therapeutic potential and mechanisms of action", FRONTIERS IN PHARMACOLOGY, vol. 12, 2021, pages 676239
P. STAHLC. WERMUTH: "Handbook of pharmaceutical salts", 2008, WILEY-VCH, pages: 127 - 133
RENIERS ET AL.: "Synthesis and evaluation of β-carboline derivatives as potential monoamine oxidase inhibitors", BIOORG. MED. CHEM., vol. 19, no. 1, 2011, pages 134 - 44, XP027577748
RUCKER, J.J.H ET AL.: "Psychiatry & psychedelic drugs. Past, present & future", NEUROPHARMACOLOGY, vol. 142, 2018, pages 200 - 218, XP085542727, DOI: 10.1016/j.neuropharm.2017.12.040

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